MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RESPIRATORY HUMIDIFIER; BTT

Model Number	MR850
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Method: the pcb of the complaint mr850 was returned to fisher & paykel healthcare in (b)(4) for investigation, where it was visually inspected and electrically evaluated.Results: visual inspection revealed no signs of impact damage.Performance testing revealed that the audible alarm could not be heard.The alarm buzzer was inspected and the coil resistance was found to be open circuit.Conclusion: we are unable to determine what may have caused the open circuit on the returned spare pcb assembly.All spare pcb assemblies undergo an operator assisted test for the function of the pcb before released for distribution.This suggests the reported damage occured after the spare pcb assembly was released for distribution.Our mr850 product technical manual contains a maintenance schedule which instructs the user to conduct annual visual checking and performance testing of the mr850 heater base.In addition the product technical manual also states that "all servicing procedures should be followed by a humidifier test, and an electrical safety test to ensure proper operation".The mr850 is equipped with visual alarm indicators in addition to the audible alarm.
Event or Problem Description
A hospital in the (b)(6) reported that the audible alarm of an mr850 respiratory humidifier had failed.There was no patient involvement.

• Brand Name: RESPIRATORY HUMIDIFIER
• Common Device Name: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 6606321
• Report Number: 9611451-2017-00491
• Device Sequence Number: 11055169
• Product Code: BTT
• UDI-Device Identifier: 09420012407184
• UDI-Public: 010942001240718410210000445611151103
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 151103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1